# FDA 483 - Hach Co - April 01, 2025

Source: https://www.keypedia.com/records/483/hach-co/b2290bb3-3824-4337-87e3-ffdc6e960509

> FDA 483 for Hach Co on April 01, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hach Co
- Inspection Date: 2025-04-01
- Product Type: device
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Hach Co in Ames, IA, identified a significant deficiency in the firm's corrective and preventive action (CAPA) procedures. The company failed to adequately address ongoing and recurring complaints regarding a speaker error in its CM 130 ultra-low chlorine analyzer, a device used for dialysis treatment. Despite a previous field action and numerous subsequent complaints, no additional corrective actions were initiated, indicating a systemic breakdown in their quality management system.

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/hach-co/179f1e12-a2f7-4fe3-ac6a-0deccf95e20f

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79